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Cancer Vaccine

mRNA-1345 Vaccine for Respiratory Syncytial Virus

Phase 2

Recruiting

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Maternal participants have received local standard of antenatal care prior to enrollment and expect to continue to do so through the remainder of their pregnancy

Maternal participants will be 28 to 36 weeks pregnant at the time of vaccination (confirmed by an obstetric ultrasound report)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to month 6 (6 months postdelivery)

Awards & highlights

Study Summary

This trial will study the safety & immunogenicity of an RSV vaccine in pregnant women & their babies to better protect them from RSV.

Who is the study for?

This trial is for pregnant women aged 18 to less than 40, who are between 28-36 weeks into their pregnancy. They must be able to attend all study visits and have had standard antenatal care. Infants born to these mothers can also participate with parental consent.Check my eligibility

What is being tested?

The trial is testing mRNA-1345, a new vaccine aimed at preventing respiratory syncytial virus (RSV). Pregnant women will receive either the vaccine or a placebo to assess safety and immune response in them and their newborns.See study design

What are the potential side effects?

Possible side effects of the mRNA-1345 vaccine may include typical reactions seen with other vaccines such as soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been and plan to continue receiving standard pregnancy care.

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I am between 28 to 36 weeks pregnant, confirmed by an ultrasound.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to month 6 (6 months postdelivery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to month 6 (6 months postdelivery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to month 6 (6 months postdelivery) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Infant Participants With Birth Outcomes

Number of Infant Participants with AESIs

Number of Infant Participants with MAAEs

+8 more

Secondary outcome measures

GMC of Serum RSV-F Binding Antibodies in Infant Participants

GMT of Serum RSV-A and RSV-B Neutralizing Antibodies in Infant Participants

Geometric Mean Concentration (GMC) of Serum RSV-F Binding Antibodies in Maternal Participants

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: mRNA-1345 Dose CExperimental Treatment1 Intervention

Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose C.

Group II: mRNA-1345 Dose BExperimental Treatment1 Intervention

Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose B.

Group III: mRNA-1345 Dose AExperimental Treatment1 Intervention

Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single intramuscular (IM) injection of mRNA-1345 Dose A.

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive single IM injection of mRNA-1345 vaccine matching placebo in the period from 28 weeks to 36 weeks of gestation.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor

108 Previous Clinical Trials

61,378,957 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment still open?

"Yes, as observed from clinicaltrials.gov, this medical trial is currently searching for volunteers to participate. This research endeavor was initially posted on November 15th 2023 and has been recently updated on the 19th of November 2023. A total of 360 patients are required across 62 various sites."

Answered by AI

In what geographical areas is this clinical experiment taking place?

"This clinical trial has 62 enrollment sites, such as SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS in Dothan, Abby's Research Institute in Phoenix and Applied Research Center of Arkansas - ClinEdge - PPDS in Little Rock. A vast array of other locations are also available for patient recruitment."

Answered by AI

Are there any specific eligibility criteria for participating in this clinical research?

"Candidates with respiratory syncytial virus that fall between 18 and 40 years of age are eligible to participate in this trial. Ultimately, a total of 360 participants will be included."

Answered by AI

Are minors allowed to participate in this trial?

"Strictly adhering to the entry requirements, this trial is open only to those aged 18-40."

Answered by AI

To what extent might mRNA-1345 Dose A endanger participants in the trial?

"The safety of mRNA-1345 Dose A was appraised as a 2 due to limited evidence from Phase 2 trials, implying that while there is some data suggesting it is safe, there are no reports proving its efficacy."

Answered by AI

What is the aggregate size of those involved in this investigation?

"To adequately complete this trial, 360 patients who fit the inclusion criteria must participate. Potential enrollees can seek out two medical facilities that are collaborating on this project: SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS in Dothan Arizona or Abby's Research Institute in Phoenix Arkansas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers

2023. "A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06143046.

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